AUTH/2673/11/13: Member of the public v Recordati — clinical trial disclosure for silodosin (Silodyx) (No breach) | PMCPA Case

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Key facts

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Case number	AUTH/2673/11/13
Complainant	Anonymous, contactable member of the public
Company	Recordati
Issue	Clinical trial disclosure (Silodyx / silodosin)
Complaint received	18 November 2013 (site listing) / 21 November 2013 (report text)
Case completed	24 March 2014
Appeal	No appeal
Applicable Code year	2006 (site listing)
Clauses considered	2, 9.1 and 21.3
Decision	No breach of the Code
Key study identifiers mentioned	NCT00359905 (EudraCT 2005-005665-11); NCT01757769 (EudraCT 2011-000045-20)
Sanctions	None stated

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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An anonymous, contactable member of the public complained about alleged late/non-disclosure of clinical trial results, based on an ABPI-funded transparency study published in Current Medical Research & Opinion (CMRO) on 11 November 2013.
The CMRO study assessed public sources (27 December 2012 to 31 January 2013) for registration and results disclosure for trials linked to 53 new medicines approved by EMA (2009–2011). Product-level detail was available via a linked website.
For silodosin (Silodyx/Silogyx), the CMRO summary showed 6 trials identified (2 unevaluable; 4 evaluable), with 3/4 disclosed within the study’s timeframe (75%), and 6/6 disclosed by 31 January 2013 (100%).
The complainant alleged breaches of Clauses 2, 9 and 21 of the Code (the Authority also drew attention to Clauses 1.8 and 21.3 of the Second 2012 Edition, and that earlier Codes might be relevant).
Recordati explained that only two trials in the CMRO analysis were sponsored by Recordati (both by Recordati Industria Chimica e Farmaceutica S.p.A.); one was ongoing at the time of the CMRO search and one completed earlier (open-label phase last patient/last visit 4 January 2008) with subsequent abstract (April 2010) and full publication (Epub 10 Nov 2010 / journal 2011).
A key issue was which “first approval and commercially available” date should trigger disclosure timelines for a medicine with multiple brand names/MAHs globally (Japan 2006; US 2008; EU Recordati 2010; first EU marketing June 2010).

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No breach of the Code.
The Panel ruled no breach of Clauses 21.3, 2 and 9.1 (Second 2012 Edition) for the Phase IV study completing July 2013 because disclosure was not due until July 2014.
The Panel ruled no breach of Clauses 9.1 and 2 (2006 Code) regarding the earlier study because key dates (last patient/last visit 4 January 2008; CSR synopsis submitted Sept–Oct 2008) were before disclosure requirements existed in the Code.
The Panel noted that even if the trigger date were treated as company-specific (Recordati EU marketing authorisation/launch June 2010), disclosure by June 2011 would have been required and had occurred.

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